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Ongoing FDAEvent 99796 (13 days ago)

Spectral CT and Spectral CT 7500 RT

Spectral CT and Spectral CT 7500 RT have software issues that may affect safety and performance.

Moderate risk

Using it may cause temporary or medically reversible health problems. Serious harm is unlikely.

FDA Class II recall · How risk is rated

What to do

What happened

Philips Medical Systems began a recall of Spectral CT and Spectral CT 7500 RT systems on August 21, 2026, due to software issues that may affect safety and performance. The issues may result in image artifacts, wrong slice thickness, or unintended system motion. The FDA added the recall to its Enforcement Report and classified it on October 2, 2026.

Summary by Recall Canary from the FDA notice.

What to do

We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:

  1. A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
  2. Talk to your health care provider before you stop using it.

Is yours affected?

Affected if its model number and UDI-DI are listed under that product.

  1. Spectral CT and Spectral CT 7500 RT

    Model
    • 728333
    • 728340
    • 728344
    • 728345
    UDI-DI
    • 00884838101111
    • 00884838127876
    • 00884838111103
    • 00884838117822
    • 00884838123748

Details

Company began the recall
Event ID
99796
Company
PHILIPS MEDICAL SYSTEMS
  1. Company began the recall

  2. Added to FDA's Enforcement Report · Classified by FDA

  3. Listed on Recall Canary

  4. In FDA's weekly enforcement report

All recalls from PHILIPS MEDICAL SYSTEMS

Summary by Recall Canary, written with AI · summary updated Oct 3, 2026 · primary source: U.S. Food and Drug Administration